The purpose of this prospective, multicentre, non-randomised translational study is to provide proof of feasibility of achieving paired biopsies for PD-L1 assessment in patients with NSCLC treated with palliative or radical radiotherapy. This is a non-CTIMP study.
All participants will have a minimum of 1 mandatory biopsy (during radiotherapy \[irradiated site\]) and the potential to have a pre-treatment biopsy if archival biopsy does not meet the suitability criteria.
Participants will have up to a maximum of 2 additional optional biopsies (during radiotherapy \[within the RT field e.g supraclavicular fossa node\], \[outside RT field e.g. skin met\]).
Blood samples will also be taken on study at specified time points for immune monitoring (exploratory endpoints).
The study will be carried out in two stages as follows:
Stage 1:
Following the enrolment of the first 15 evaluable participants, an interim analysis will take place by the Trial Steering Committee (TSC). The TSC will make a recommendation on whether recruitment should continue to the Trial Management Group (TMG).
Stage 2:
A further 15 evaluable participants will be recruited onto the study to achieve a total of 30 evaluable participants.
